Z-1781-2018Class II

NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information...

Name: Z-1781-2018 NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information...
Creator: Ninepoint Medical Inc.
Published: 2018-04-11
License: https://open.fda.gov/license/

Ninepoint Medical, Inc. / initiated 2018-04-11 / Terminated / root cause: manufacturing process

FDA source

Ninepoint Medical Inc. began a recall of NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196)... on 2018-04-11. FDA classified it as Class II and gives the reason as "Distal tips of the probes may detach from the probe shaft during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1781-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Posted: 2018-05-09
Terminated: 2018-08-20
Recalling firm: Ninepoint Medical, Inc.
Product: NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.
Product code: NQQ System, Imaging, Optical Coherence Tomography (Oct)
Reason for recall: Distal tips of the probes may detach from the probe shaft during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 11, 2018 Ninepoint Medical Inc. mailed Urgent Medical Device Recall letters to affected customers. Customers were instructed to examine inventory for the affected product, discontinue use of affected product, complete a recall response form or send the information via email to [email protected], in order to initiate the product return process. Customers with questions may contact the NinePoint Medical Recall Coordinator at (855)900-7195 or [email protected].
Quantity in commerce: 152
Distribution: US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
Product codes and lots: Lot Numbers: 005196, 005251, 005275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1781-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1781-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code NQQ

K143678Class IINvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. / cleared 2015-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)